Tresiba (insulin degludec) is a once-daily basal insulin for diabetes in adults and children from 1 year, supplied as FlexTouch pens at 100 and 200 units/mL, and every consignment is a cold-chain job.
M Care Exports supplies Tresiba (insulin degludec), the Novo Nordisk basal insulin, together with its combination brands Ryzodeg and Xultophy where a destination's registration allows. We are a merchant exporter, so we quote the brand against your import permit and storage capacity, with temperature-controlled lanes to hospitals, importers and tender desks in the GCC, Africa and the UK.
Insulin degludec exporter and bulk supplier from India.
"I'm looking for Tresiba" is an enquiry that usually comes with a pen strength and a cold-chain question attached. M Care Exports quotes Tresiba per destination against the buyer's specification: FlexTouch pen at 100 units/mL or 200 units/mL, or the 10 mL multiple-dose vial where the destination registers it. We confirm the registered presentation in your country before quoting, because the US label lists a vial and a U-200 pen while the EU product information lists cartridge and pre-filled pen presentations. Quantity is set by the strength and pack you order, and we state the minimum remaining shelf life on the proforma.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Long-acting human insulin analogue (basal insulin), sourced and documented for export.
Insulin degludec is a long-acting human insulin analogue given by subcutaneous injection, once daily. The FDA label indicates it to improve glycaemic control in patients 1 year of age and older with diabetes mellitus, and states it is not recommended for treating diabetic ketoacidosis. The EU and UK product information covers adults, adolescents and children from the age of 1 year. The US label lists three presentations: a 3 mL U-100 FlexTouch pen, a 10 mL U-100 multiple-dose vial and a 3 mL U-200 FlexTouch pen. The U-100 pen dials 1 unit at a time up to 80 units per injection, and the U-200 pen dials 2 units at a time up to 160 units. Unopened product is stored at 2 to 8 degrees C. The same brand family includes Ryzodeg (insulin degludec with insulin aspart, authorised in the EU) and Xultophy (insulin degludec with liraglutide, for type 2 diabetes, authorised in the EU and carrying a US DailyMed label).
Active ingredient
Insulin degludec. Long-acting human insulin analogue (basal insulin).
Forms and strengths
100 units/mL, 3 mL FlexTouch prefilled pen; 200 units/mL, 3 mL FlexTouch prefilled pen; 100 units/mL, 10 mL multiple-dose vial (US presentation).
Indications
Insulin degludec, a long-acting basal insulin analogue indicated to improve glycaemic control in diabetes mellitus in patients from 1 year of age. Supplied as originator Tresiba, with the Ryzodeg and Xultophy combinations, through cold-chain export to regulated and semi-regulated markets outside India.
Administration
Subcutaneous. Solution for injection in pre-filled pen, cartridge or multiple-dose vial.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Tresiba buyers are hospital and outpatient diabetes pharmacies, national and regional MoH tender desks that list basal insulin analogues, licensed importers and pharmaceutical wholesalers, and NGO or foundation programmes that need a reliable pen supply with a documented cold chain. If your tender asks for a long-acting insulin analogue by class, we can quote the Tresiba pen or discuss other analogue options, and we do not turn a request away because the brand is not on a catalogue page. "We need a partner for Tresiba" is a typical opening line from an importer who has the registration but not the lane.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on insulin degludec.
Treat the two Tresiba pens as separate products at the bedside. The label says not to perform dose conversion between the U-100 and U-200 FlexTouch pens: the dose window shows units either way, but the U-200 pen moves in 2-unit steps up to 160 units, so a 1-unit dose needs the U-100 pen. Adults on once-daily dosing can inject at any time of day, but at least 8 hours must separate consecutive injections, and dose increases are spaced 3 to 4 days apart. Tresiba must not be given intravenously or in an insulin infusion pump, must not be drawn from the pen into a syringe, and the pen must never be shared, even with a changed needle. Hypoglycaemia is the most common adverse reaction of insulin, so check potassium in patients at risk of hypokalaemia and watch for heart failure signs when a thiazolidinedione is co-prescribed. On the cold-chain side, unopened pens keep to expiry at 2 to 8 degrees C, never frozen, and the label allows 56 days at up to 30 degrees C for unopened or in-use product.
The documentation pack a regulator actually asks for.
Tresiba is a cold-chain biological, so documentation centres on temperature evidence as much as the dossier: pre-shipment thermal validation, in-transit loggers and an on-arrival record, with the 30-month shelf life and the 8-week limit after first opening or as a spare stated in the UK SmPC used to set minimum remaining shelf life per order. We supply batch certificates of analysis, importing-country labelling and CTD or eCTD dossier support where your regulator requires it. Insulin degludec is a branded originator product of Novo Nordisk, authorised centrally in the EU on 21 January 2013, and Tresiba is listed on its EMA page as a standalone authorised medicine. The WHO Model List of Essential Medicines carries long-acting insulin analogues (degludec, detemir, glargine) on the core list, and the WHO committee recommended extending the listing to 10 mL vials alongside the 3 mL cartridge and pen. Registration status in individual GCC and African countries differs, so we verify it with the national regulator before each quote.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside insulin degludec.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for insulin degludec.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Insulin degludec supply, the specific questions.
What is the Tresiba price, and how does M Care quote it?
We do not publish a Tresiba price, because the landed price for an importer depends on several variables: whether you want the originator brand or an alternative basal insulin, the pen strength and pack (U-100 or U-200 FlexTouch, or the vial where registered), order quantity, the destination's registration route, temperature-controlled freight, and Incoterms. M Care Exports quotes per destination, so send the country, strength, quantity and import permit status and we return a written offer for that route.
What is the generic name of Tresiba, and is there a generic?
The generic name is insulin degludec. In the US, the DailyMed label for Tresiba is held by Novo Nordisk. In the EU, the EMA page lists Tresiba as an authorised medicine held by Novo Nordisk and does not name a generic or biosimilar for it. For India we have not cited a regulator source on a degludec equivalent, so we do not treat any product as interchangeable with Tresiba. Tell us your tender wording and we confirm what is registered in your destination before we quote.
Is Tresiba 200 units/mL the same as the 100 units/mL pen?
It is the same insulin at twice the concentration, in a different pen. The US label lists a 3 mL U-100 FlexTouch pen (1-unit steps, up to 80 units per injection), a 10 mL U-100 vial and a 3 mL U-200 FlexTouch pen (2-unit steps, up to 160 units). The label says not to perform dose conversion between the pens, because the dose window shows units for each. A 1-unit dose needs the U-100 pen. We quote against the strength your formulary lists, and your regulator must have registered it.
Can you supply an alternative to Tresiba, or compare Tresiba with insulin glargine?
Insulin glargine is a different molecule, so a tender that names only Tresiba cannot be filled with it, while a tender that asks for a long-acting insulin analogue can. The WHO Model List of Essential Medicines lists degludec, detemir and glargine together as long-acting insulin analogues on its core list. We can quote either route, but we leave clinical comparisons between the two to your formulary committee. Tell us whether the tender is brand-specific or class-based, and we will quote that specification.
How do you ship Tresiba pens and what happens if they warm up?
Pens ship in insulated cold-chain packs with temperature loggers. Unopened Tresiba stays at 2 to 8 degrees C until its expiry date and must not be frozen. The US label allows 56 days (8 weeks) at up to 30 degrees C for unopened or in-use product, and the UK SmPC gives a maximum of 8 weeks not above 30 degrees C after first opening or as a spare, so we time dispatch to your receiving capacity, supply the logger data on arrival and agree an excursion protocol before the first shipment.
Can M Care supply Ryzodeg and Xultophy as well as Tresiba?
Yes, as separate quoted products. Ryzodeg (insulin degludec with insulin aspart) is authorised in the EU and held by Novo Nordisk, and Xultophy (insulin degludec with liraglutide) is authorised for type 2 diabetes in the EU and carries a US DailyMed label. They are not interchangeable with Tresiba, so tell us which one your registration covers. We check availability and the destination's status before we quote.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.